Cleared Traditional

K801702 - SUR-FIT SYSTEM PRE-OPERATION SET

K801702 is the FDA 510(k) clearance for SUR-FIT SYSTEM PRE-OPERATION SET by E. R. Squibb & Sons, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801702 · E. R. Squibb & Sons, Inc. · Gastroenterology & Urology device
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Aug 1980
Decision
34d
Days
Class 1
Risk

K801702 is an FDA 510(k) clearance for the SUR-FIT SYSTEM PRE-OPERATION SET. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E. R. Squibb & Sons, Inc. devices

Submission Details

510(k) Number K801702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 27, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 130d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 65
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K801702.
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082 · Johnson & Johnson Professionals, Inc. · Dec 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677 · Johnson & Johnson Professionals, Inc. · Nov 1980
SUR-FIT SYSTEM STERILE O.R. SETS
K801703 · E. R. Squibb & Sons, Inc. · Sep 1980
HOLLISTER KARAYA SEAL RING
K801503 · Hollister, Inc. · Aug 1980
SUPER BANISH DEODORANT
K801471 · Howmedica Corp. · Jul 1980
SUR-FIT UROSTOMY POUCH & URINARY BAG
K800495 · E. R. Squibb & Sons, Inc. · Apr 1980